Tricuspid RegurgitationEuroTRNCT06307262
European Registry of Transcatheter Repair for Tricuspid Regurgitation
An observational study of Tricuspid Regurgitation and Valvular Heart Disease, run by LMU Klinikum at 1 site in Germany.
Trial summary
To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation, Valvular Heart Disease, Heart Failure
- What is being tested?
- T-TEER
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- 23 Oct 2023to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with one of the following transcatheter devices for TV repair or replacement (e.g. PASCAL, TriClip, TricValve, Evoque, LuX-Valve)
Who may be able to join
- Patients treated with one of the following transcatheter devices for TV repair or replacement: PASCAL, TriClip, TricValve, Evoque, LuX-Valve
- Age ≥ 18 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lukas Stolz, Dr. contact
Germany1 site, 1 recruiting
- Recruiting
LMU Klinikum
Munich, Bavaria, 81377
Jörg Hausleiter, Prof. Dr., +49 89 4400 72360, Joerg.Hausleiter@med.uni-muenchen.de
Lukas Stolz, Dr., Lukas.Stolz@med.uni-muenchen.de
About this study
Official title: European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR)
To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.
Read the detailed description
Background and Rationale:
Tricuspid regurgitation (TR) is a major health and economic burden due to high rates of heart failure hospitalizations, morbidity and mortality. Surcial treatment of TR is associated with high procedural and in-hospital mortality. Due to prohibitive surgical risk, a significant proportion of patients historically remained untreted beyond medical therapy. Transcatheter tricuspid valve (TV) repair and replacement techniques (TTVT) now offer a new treatment perspective for these patients. The EuroTR registry aims at optimizing patient selection prior to TTVT and thus treatment quality by collecting respective data in a real-world setting.
Objectives:
To investigate clinical and survival outcome following transcatheter tricuspid valve repair or replacement.
- Being tested
- T-TEER
- Keywords
- Tricuspid regurgitation, TEER, edge-to-edge repair
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Valve Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-TEERDevice
Also called Transcatheter tricuspid valve edge-to-edge repair
T-TEER using the PACAL or TriClip device
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 5 years
Secondary outcomes (12)
Technical success
absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery
Measured: 5 years
Procedural Safety
periprocedural and in-hospital adverse events
Measured: 5 years
Heart Failure Biomarker
NT-proBNP level
Measured: 5 years
Dyspnea on exertion
New York Heart Association (NYHA) functional class
Measured: 5 years
Functional capacity
6-minute walk distance (6MWD)
Measured: 5 years
Right ventricular size
Mid-ventricular diameter of the right ventricle measured by echocardiography
Measured: 5 years
Right ventricular function
Right ventricular fractional area change measured by echocardiography
Measured: 5 years
Tricuspid regurgitation reduction
Tricuspid regurgitation severity measured by echocardiography
Measured: 5 years
Tricuspid valve stenosis
Transvalvular pressure gradient measured by echocardiography
Measured: 5 years
Pulmonary hypertension
Pulmonary artery pressure measured by echocardiography
Measured: 5 years
Right heart congestion
Inferior vena cava dimensions measured by echocardiography
Measured: 5 years
Hospitalization for heart failure
Date and number of heart failure hospitalizations after the index procedure
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start23 Oct 2023
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Jörg Hausleiter, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307262
- Sponsor's protocol ID
- EuroTR Registry
- Acronym
- EuroTR
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Masiero G, Arturi F, Ceni S, Panza A, Kresoja KP, von Stein J, Fortmeier V, Koell B, Rottbauer W, Kassar M, Goebel B, Denti P, Achouh P, Rassaf T, Barreiro-Perez M, Boekstegers P, Ruck A, Zdanyte M, Adamo M, Vincent F, Schlegel P, Rosch S, Wild MG, Besler C, Toggweiler S, Brunner S, Grapsa J, Patterson T, Thiele H, Kister T, Sticchi A, De Carlo M, Voss F, Polzin A, Popolo Rubbio A, Bedogni F, Stolte T, Nestelberger T, Benito-Gonzalez T, Sanchez-Munoz E, Konstandin MH, Van Belle E, Metra M, Geisler T, Estevez-Loureiro R, Mahabadi AA, Karam N, Maisano F, Lauten P, Praz F, Kessler M, Kalbacher D, Rudolph V, Iliadis C, Lurz P, Hausleiter J, Stolz L, Tarantini G; EuroTR Investigators. Invasive Hemodynamics and Risk Stratification in T-TEER: Moving Beyond ESC Thresholds - EuroTR Registry Insights. Circ Cardiovasc Interv. 2026 Jan;19(1):e015964. doi: 10.1161/CIRCINTERVENTIONS.125.015964. Epub 2025 Nov 14.
PubMed 41235431
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR)
- ClinicalTrials.gov ID
- NCT06307262
- Acronym / sponsor ID
- EuroTR / EuroTR Registry
- Keywords
- Tricuspid regurgitation, TEER, edge-to-edge repair
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.
Detailed description
Background and Rationale:
Tricuspid regurgitation (TR) is a major health and economic burden due to high rates of heart failure hospitalizations, morbidity and mortality. Surcial treatment of TR is associated with high procedural and in-hospital mortality. Due to prohibitive surgical risk, a significant proportion of patients historically remained untreted beyond medical therapy. Transcatheter tricuspid valve (TV) repair and replacement techniques (TTVT) now offer a new treatment perspective for these patients. The EuroTR registry aims at optimizing patient selection prior to TTVT and thus treatment quality by collecting respective data in a real-world setting.
Objectives:
To investigate clinical and survival outcome following transcatheter tricuspid valve repair or replacement.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with one of the following transcatheter devices for TV repair or replacement (e.g. PASCAL, TriClip, TricValve, Evoque, LuX-Valve)
Key inclusion criteria (2 listed)
- Patients treated with one of the following transcatheter devices for TV repair or replacement: PASCAL, TriClip, TricValve, Evoque, LuX-Valve
- Age ≥ 18 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-TEERAlso: Transcatheter tricuspid valve edge-to-edge repairT-TEER using the PACAL or TriClip device | Device | – |
Primary outcome
All-cause mortality
Time frame: 5 years
12 secondary outcomes
Technical success
Time frame: 5 years
Procedural Safety
Time frame: 5 years
Heart Failure Biomarker
Time frame: 5 years
Dyspnea on exertion
Time frame: 5 years
Functional capacity
Time frame: 5 years
Right ventricular size
Time frame: 5 years
Right ventricular function
Time frame: 5 years
Tricuspid regurgitation reduction
Time frame: 5 years
Tricuspid valve stenosis
Time frame: 5 years
Pulmonary hypertension
Time frame: 5 years
Right heart congestion
Time frame: 5 years
Hospitalization for heart failure
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 41235431Masiero G, Arturi F, Ceni S, Panza A, Kresoja KP, von Stein J, Fortmeier V, Koell B, Rottbauer W, Kassar M, Goebel B, Denti P, Achouh P, Rassaf T, Barreiro-Perez M, Boekstegers P, Ruck A, Zdanyte M, Adamo M, Vincent F, Schlegel P, Rosch S, Wild MG, Besler C, Toggweiler S, Brunner S, Grapsa J, Patterson T, Thiele H, Kister T, Sticchi A, De Carlo M, Voss F, Polzin A, Popolo Rubbio A, Bedogni F, Stolte T, Nestelberger T, Benito-Gonzalez T, Sanchez-Munoz E, Konstandin MH, Van Belle E, Metra M, Geisler T, Estevez-Loureiro R, Mahabadi AA, Karam N, Maisano F, Lauten P, Praz F, Kessler M, Kalbacher D, Rudolph V, Iliadis C, Lurz P, Hausleiter J, Stolz L, Tarantini G; EuroTR Investigators. Invasive Hemodynamics and Risk Stratification in T-TEER: Moving Beyond ESC Thresholds - EuroTR Registry Insights. Circ Cardiovasc Interv. 2026 Jan;19(1):e015964. doi: 10.1161/CIRCINTERVENTIONS.125.015964. Epub 2025 Nov 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lukas Stolz, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation and Valvular Heart Disease, run by LMU Klinikum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jörg Hausleiter, Prof. Dr. (+49 89 4400 72360, Joerg.Hausleiter@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06307262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.